Is It Okay to Sign Up a Loved One with Alzheimer’s for a Research Study?

November 7, 2005

Is it okay to sign a loved one up for a research study testing a new drug or treatment for Alzheimer’s disease, even if he or she does not really understand the potential risks and benefits involved? This ethically fraught question is becoming increasingly common, thanks to a growing number of clinical trials involving potentially risky new therapies and the swelling ranks of people with Alzheimer’s disease in our aging population. A new study in Neurology, the journal of the American Academy of Neurology, sheds light on the delicate issues involved and reveals that family members are often willing to give their consent to new treatments and procedures, even for potentially risky therapies in loved ones who are incapacitated and unable to make rational choices for themselves.

“As potential new therapies such as vaccines, gene therapy, and new drugs are being tested, the need for research must be balanced with the need to protect vulnerable adults,” said study leader Scott Y. H. Kim, M.D., Ph.D., of the University of Michigan Medical School in Ann Arbor. “This continues to be an area with unsettled policy, and there is little data to guide policymakers. It doesn’t seem ideal to leave these important ethical questions solely to politics. This study shows that it’s possible to learn the views of key stakeholder groups, and they can provide important insights.”

For their study, the Michigan researchers enlisted 229 people at heightened risk for Alzheimer’s disease. All were age 70 and up and had at least one close relative with the disease. Participants were given 10 research scenarios and asked if the research portrayed was acceptable when it involves people with Alzheimer’s who cannot give their own informed consent and are enrolled with a family member’s permission.

The study volunteers were asked to consider the question of study participation from three perspectives:

1) Is the research acceptable from a broad societal perspective?
2) Would you want a loved one to make the decision for you? (a personal perspective)
3) How would you make a decision for a loved one? (a surrogate’s perspective)

The 10 scenarios ranged from low-risk studies involving observation of a patient’s behavior or routine blood tests to higher-risk studies like testing a potential new vaccine or gene-transfer experiments involving brain surgery. The survey participants were told about the risks and any potential benefits to subjects or to society.

More than 90 percent of the participants felt that minimal risk studies as well as randomized clinical trials of new medicines should be allowed for people with Alzheimer’s who cannot make competent decisions, provided that family members give permission. A smaller proportion, but still a majority, felt that even high-risk research studies, such as those involving potentially fatal brain surgery, were acceptable.

In general, participants endorsed family consent for research most strongly when applied to themselves as future research subjects and least strongly when placing themselves in the position of the surrogate having to decide for a loved one. For example, for a study that would involve a lumbar puncture (also known as a spinal tap), family consent for research was endorsed by 69 percent when applied to themselves as future subjects, by 65 percent from a social policy perspective, and by 61 percent as something they would allow for a loved one.

Participants were more likely to find the research scenarios acceptable if they had a generally supportive attitude toward biomedical research. The study participants were already taking part in an Alzheimer’s disease anti-inflammatory prevention research study. The researchers note that the participants could be more supportive of research than the typical person at risk for Alzheimer’s. “However, those taking part in the study were fairly typical demographically to people taking part in other studies of Alzheimer’s disease, so they may be quite similar to those likely to be considered for future research studies,” Kim said.

Still, the researchers note, a substantial minority of those surveyed would not endorse high-risk experimental treatments for themselves, and even more would not accept it for a loved one with advanced Alzheimer’s disease. The findings highlight the delicate ethical issues involved in making a decision for a loved one with dementia and underscore the importance of discussing such issues among family members, health professionals, and researchers.

Choosing to participate in a research study is an important personal decision. For more information about clinical trials, including answers to frequently asked questions, visit the www.ALZinfo.org. In addition, it is often helpful to talk to your healthcare provider, family members, or friends about deciding to join a trial. After you have identified some trial options, the next step is to contact the study research staff and ask questions about specific trials. Search the National Library of Medicine’s clinical trials database to locate clinical trials investigating Alzheimer’s disease.

By www.ALZinfo.org, The Alzheimer’s Information Site. Reviewed by William J. Netzer, Ph.D., Fisher Center for Alzheimer’s Research Foundation at The Rockefeller University.